Question 1

Which of the following is not a terminal sterilization process?

Options :

A : Moist heat sterilization processing

B : Ethylene Oxide sterilization processing

C : Aseptic processing

Answer: C

Question 2

The term or period during which a commodity remains suitable for the intended use is called ________.

Options :

A : Intended use period

B : Usage life

C : Suitable life

D : Shelf life

Answer: D

Question 3

ISO/IEC 17025 standard is applicable to _______________.

Options :

A : First- & Second- party laboratories

B : First party laboratories

C : Second-, and Third- party laboratories

D : First-, Second-, and Third- party laboratories

Answer: D

Question 4

According to 21 CFR 830, generally the UDI rule requires a UDI of a device on ______________.

Options :

A : Device label and package

B : Device package

C : Device itself as a permanent UDI

D : Device label

Answer: A

Question 5

If resterilization is indicated due to a process nonconformity, the effect of resterilization on the product and packaging should have been ______________.

Options :

A : Determined in the validation study to allow such reprocessing

B : Determined in the verification study to allow such reprocessing

C : Design master record (DMR)

D : Recorded on product label

Answer: A